Recent events at the United States Food and Drug Administration (FDA) have raised serious issues about the integrity of our public health infrastructure and the influence of politics and cronyism within the agency.

On-going Controversy around Emergency Contraception

In the most pressing example for advocates of sexual and reproductive health, the status of emergency contraception (EC) within the FDA continues to be embroiled in controversy, and has helped demonstrate the lack of integrity at the FDA.

On August 31, Susan F. Wood, the FDA official in charge of women’s health issues resigned in objection to the FDA’s decision to further delay a final ruling on whether one form of EC, known as Plan B, would be made available for over-the-counter (OTC) sales.¹ She stated that she was leaving her position because of the FDA’s delay in the decision announced by then-newly appointed Commissioner Lester M. Crawford.²

Wood stated that this latest decision to delay the ruling was not made in the usual manner of the FDA, but instead “at the commissioner level…where most if not all of the professional staff were excluded.”³

Crawford received the Senate’s nod this summer only after assuring Senators Hillary Rodham-Clinton (D-NY) and Patty Murray (D-WA) that a final decision on Plan B would be made by September 1 st . Going against his own word, Crawford announced on August 26 th that the decision would be further delayed. He explained that although OTC sales to women 17 and older would be safe, younger teens would still need a prescription due to concerns of their capacity to utilize the drug properly.⁴ This raised additional concerns of whether or not a product could be sold both OTC and with a prescription in the same packaging. Crawford stated that the FDA is both a scientific and a regulatory agency, and that this posed unique regulatory issues that need to be addressed before a final decision is made.

Unfortunately, this most recent delay has become an all-too-familiar pattern and suggests that politics continue to trump science at the beleaguered agency.

Plan B, a brand of emergency contraceptive pills, is a high dose of regular birth control pills that if taken within 72 hours of unprotected sex can lower the risk of pregnancy by up to 89%.⁵ Almost two years ago, the FDA’s own expert staff and advisory panels overwhelmingly voted to make Plan B available OTC. OTC status is also favored by the American Medical Association (AMA), the American Academy of Pediatrics (AAP), the American College of Obstetricians and Gynecologists (ACOG) and more than 70 other medical and public health organizations.⁶

It appears as though the agency continues to issue roadblocks simply to stall the efforts of those interested in improving women’s health. The agency has clear scientific evidence of the safety and efficacy of the medication, yet continues to delay women access based on mundane regulatory issues. Since the initial vote, additional studies have been published strengthening an already well-built case for OTC status. These new studies demonstrate that easy access to EC improves the chances of a women obtaining and using the drug in the suggested time frame without increasing rates of unprotected intercourse or the risk of sexually transmitted infections (STIs) among adolescents or adults.⁷ Research and the FDA’s own experts confirm that the proposed age restriction is unwarranted; nevertheless, even with the restriction, approval of Plan B for OTC status by the FDA would still improve access to back-up birth control, help prevent unintended pregnancies, and reduce the need for abortion.⁸

In her remarks to colleagues upon her resignation, Wood stated that the FDA has never previously raised questions regarding teens’ use of other drugs. “I have spent the last 15 years working to ensure that science informs good health-policy decisions,” Wood said. “I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended by the professional staff here, has been overruled,” she concluded.⁹

Opponents of reproductive health services, including Plan B, have lobbied the Bush administration to reject OTC sales because they consider it an abortifacient. They praised the recent delay by Crawford, stating that easier access to EC encourages sexual promiscuity, and does nothing to decrease rates of unintended pregnancies or abortions.¹⁰ The Policy Director for Concerned Women of America (CWA), Wendy Wright, welcomed Wood’s resignation, stating, “thank goodness there is now one less political activist at the FDA who puts radical feminist ideology above women’s health. Now that Susan Wood has some free time on her hands, she can look at the studies from countries that have made the morning-after pill available without a prescription. She’ll find it creates a public health hazard, with no decrease in pregnancies, no decrease in abortion, but a substantial increase in sexually transmitted diseases.”¹¹ This so-called research, however, has not surfaced in all the prior debate.

Wood’s resignation was an unparalleled public show of dissension for the FDA. It drew a great deal of media attention and prompted additional moves from lawmakers. Many supporters of the Plan B application for OTC status, including Senators Clinton and Murray, accused Crawford of making a political decision that ignored science and public health. “It is time for the FDA to stop playing games with the health and well-being of millions of American women,” the Senators said in a joint statement. “Day by day, the public’s confidence in the FDA’s ability to make decisions based on scientific evidence of safety and efficacy is eroding.”¹²

Senators Clinton and Murray called for the chairman of the Senate Committee on Health, Education, Labor and Pensions, Senator Michael Enzi (R-WY), to hold a hearing on the latest delay. ¹³ A spokesman for Senator Enzi stated that he is considering their request for a hearing, and has separately asked the FDA to explain how and why it reached this latest decision.¹⁴ Senators Murray and Clinton have also asked the Government Accountability Office (GAO) to finally release its report over FDA handling of Plan B, a report requested by them last summer. “This is not game over, this is game on,” Murray said, adding she was not about to give up.¹⁵ In a separate letter, four House Democrats asked President Bush to issue “a clear directive” to federal agencies that all health-related decisions are to be based on science.¹⁶

On September 21 st , during Senate hearings on the Fiscal Year 2006 Agriculture Appropriations bill Senators Murray and Clinton issued a statement about the FDA and Crawford’s leadership on the Senate floor stating that, “with the resignation of Dr. Crawford, the FDA has a real opportunity to restore its battered reputation and nominate a leader with vision and drive to ensure that the FDA upholds its gold standard of drug regulation.” succeeded in persuading colleagues to include language in the agency’s final appropriations bill expressing congressional concern over the direction of the FDA and calling for an expedited decision on Plan B.¹⁷

Controversial Appointments

On September 13th, an email was sent to various women’s groups by the Office of Women’s Health announcing Norris Alderson as the new acting director in place of Wood. Alderson is a long time FDA staff member trained in animal husbandry and has spent much of his career in the agency’s Center for Veterinary Medicine.¹⁸

Alderson quickly became the subject of controversy and the FDA press office sent out a very different announcement just three days later stating that 20-year FDA veteran Theresa A. Toigo would be the new acting director of the office. The statement regarding Alderson was never mentioned. When questioned, FDA spokeswoman Suzanne Trevino stated that Alderson had never been appointed acting director. “There was no official decision made until we announced Theresa Toigo’s appointment,” Trevino said.¹⁹

Then, in a surprise move, Commissioner Crawford resigned on September 23rd, just two months after his confirmation, stating in an email to colleagues, “after three and a half years as deputy commissioner, acting commissioner and, finally, as commissioner, it is time, at the age of 67 to step aside.” In addition to saying he was worn out by working 20-hour days, Crawford stated that several other factors contributed to his decision including thing controversies over Plan B as well as the abortion pill known as RU-486. Crawford said he didn’t feel ready to deal with another set of such controversies. “Another year of that stuff,” he said, “I didn’t think I was up to it.”²⁰ Crawford, a veterinarian and food safety expert, became the FDA deputy commissioner in 2002 and later became acting agency commissioner. The agency had been accused of being lenient in its safety requirements while under Crawford’s leadership, after the discovery a year ago that the popular arthritis drug Vioxx increased the risk of heart attacks and stroke. The agency suffered additional criticism regarding malfunctioning heart devices as well as the Plan B issue.²¹

Crawford’s resignation caused speculation, with some reports implying that his resignation was due to exclusions on his financial disclosure form. Financial disclosure forms are required of upper-level management to prevent conflicts of interest and to ensure that no individual is gaining financially from decisions made by the agency. HHS officials would not comment on the reports, calling it a personnel matter. Crawford says that, to his knowledge, he did not own any shares of companies that were regulated by the FDA during his tenure as acting commissioner. He does admit to owning some paper companies but states that they were promptly sold when they became regulated by the FDA during his tenure.²²

President Bush named Andrew von Eschenbach, the director of the National Cancer Institute (NCI), as the acting FDA commissioner. In an email to cancer research advocates, von Eschenbach called his appointment “an interim role.”²³ His nomination has also been met with criticism from political leaders such as Senate Finance Committee Chair Chuck Grassley (R-Iowa) who felt that an individual who heads both the FDA and NCI will not have the ability to “dedicate 100% of his or her time and talent to the nation’s public health and safety agency.”²⁴

In another controversial appointment, Scott Gottlieb was named Deputy Commissioner for Medical and Scientific Affairs on July 29th. Gottlieb is referred to by some as a “doctor turned-stock-analyst” due to his extensive background in finance. Former FDA Commissioner Donald Kennedy, who is now the executive editor-in-chief of the journal Science , stated, “the appointment comes out of nowhere. I’ve never seen anything like that.”²⁵

In recent weeks Gottlieb has questioned key decisions made by the FDA, such as the decision not to approve Oporia, a drug for osteoporosis. If it stands,the FDA’s decision could cost the drug company Pfizer $1 billion in annual revenue. A scientist at the FDA told TIME magazine that this “really confirmed people’s worst fears that he was only going to be happy if we were acting in a way that would make the pharmaceutical industry happy.”²⁶

According to William Smith, the vice president for public policy at SIECUS, nowhere in the federal government is it more essential that officials be appointed on merit and expertise rather than political clout, than it is at the FDA. “This agency is solely responsible for assuring the safety of numerous products including vaccines, medications, animal feed, and beauty products. Unfortunately, it seems that top officials have been selected based on who they know and their ability to further a political ideology, while those who are qualified and have been working tirelessly to put the best scientific evidence into practice have had to resign in protest.”

References

1. Marc Kaufman, “FDA Official Quits Over Delay on Plan B,” The Washington Post, 1 September 2005 , A08.
2. Ibid.
3. Lauren Neergaard, “FDA Official Quits Over Plan B Delay,” The San Francisco Gate, 31 August 2005 , accessed 16 September 2005 <http://www.sfgate.com>.
4. Ibid.
5. Ibid.
6. Reproductive Health Technologies Project, “Plan B Over-the-Counter Application,” Press Release published 16 August 2005, accessed 28 September 2005, <http://www.rhtp.org>.
7. Ibid.
8. Ibid.
9. Rita Rubin, “FDA Official Quits Over Plan B Pill Delay,” USA Today, 31 August 2005, accessed 19 September 2005 , <http://www.usatoday.com>.
10. Ibid.
11. Marc Kaufmann, “FDA Official Quits.”
12. Neergaard.
13. Ibid.
14. Les Blumenthal, “Murray Hot Over Delayed Decision,” The Tri-City Herald , 11 September 2005, accessed 18 September 2005, <http://www.tri-cityherald.com>.
15. Ibid.
16. Neergaard.
17. Marc Kaufman, “FDA Commissioner Steps Down After Two Month Rocky Tenure,” The Washington Post, 24 September 2005 , accessed 27 September 2005, <http://www.washingtonpost.com>.
18. Marc Kaufman, “FDA Re-thinks Women’s Chief,” The Washington Post, 20 September 2005, A21
19. Ibid.
20. Matthew Herper, “Former FDA Chief Denies Financial Conflicts,” Forbes, 28 September 2005, accessed 4 October 2005, <http://www.forbes.com>.
21. Kaufman, “FDA Commissioner Steps Down.”
22. Associated Press, “Senators Question FDA’s Head’s Resignation,” MSNBC, 29 September 2005, accessed 5 October 2005, <http://msnbc.msn.com>.
23. Rita Rubin, “FDA’s Commissioner Post Could be Difficult to Fill, “ USA Today, 25 September 2005, accessed 27 September 2005, <http://www.usatoday.com>.
24. Ibid.
25. Mark Thompson, Karen Tumulty, & Mike Allen, “How Many More Mike Browns Are Out There?” Time Magazine, 27 September 2005, accessed 28 September 2005, <http://www.cnn.com>.
26. Ibid.